Deltex Medical L T D

FDA Filings

This page includes the latest FDA filings for Deltex Medical L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Deltex Medical L T D holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number9680933
FEI Number1000637007
NameDonna Connolly
Owner & OperatorDELTEX MEDICAL LIMITED
Contact AddressTERMINUS ROAD
CHICHESTER GB-WSX West Sussex PO19 8TX GB
Official Correspondent
  • Graham Lowe
  • 44-1243-774-837
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressDeltex Medical SC, Inc. 330 E. Coffee Street
Greenville, SC 29601 US
Establishment TypeManufacture Medical Device



Registration Number3003942238
FEI Number3003942238
NameDeltex Medical SC, Inc.
Owner & OperatorDELTEX MEDICAL LIMITED
Contact AddressTERMINUS ROAD
CHICHESTER GB-WSX West Sussex PO19 8TX GB
Official Correspondent
  • Graham Lowe
  • 44-1243-774-837
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address330 E. Coffee Street
Greenville, SC 29601 US



FDA Filings

Device
Company
DeviceDate
DELTEX MEDICAL LIMITED
DP240 Doppler Probe 2020-02-12
DELTEX MEDICAL LIMITED
HD-ICG Electrode Convenience Kits 7057-70052019-03-11
Donna Connolly [DELTEX MEDICAL LIMITED]
HD-ICG Hub2018-11-29
DELTEX MEDICAL LIMITED
KDP72 Doppler Probe 2018-07-06
DELTEX MEDICAL LIMITED
I2P24 Doppler Probe 2018-07-06
DELTEX MEDICAL LIMITED
I2S6 Doppler Probe 2018-07-06
DELTEX MEDICAL LIMITED
Deltex Medical CardioQ EDM+ 2018-07-06
DELTEX MEDICAL LIMITED
Deltex Medical CardioQ EDM 2018-07-06
DELTEX MEDICAL LIMITED
I2C72 Doppler Probe 2018-07-06
Deltex Medical Limited
Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM2018-06-28
Donna Connolly [DELTEX MEDICAL LIMITED]
KDP72 Doppler Probe2015-12-17
DELTEX MEDICAL LIMITED
Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+2015-07-24
DELTEX MEDICAL LIMITED
Deltex Medical KDP72 Doppler Probe2015-01-22
Donna Connolly [DELTEX MEDICAL LIMITED]
CardioQ-EDM+ Cardiac Function and Fluid Status Monitoring System2013-11-11
DELTEX MEDICAL LIMITED
DELTEX MEDICAL CARDIOQ-EDM+2013-10-10
Donna Connolly [DELTEX MEDICAL LIMITED]
CardioQ-EDM Cardiac Function and Fluid Status Monitoring Sys2011-11-04
Donna Connolly [DELTEX MEDICAL LIMITED]
CardioQ-EDM Cardiac Function and Fluid Status Monitoring Sys2011-11-04
Donna Connolly [DELTEX MEDICAL LIMITED]
CardioQ-EDM Cardiac Function and Fluid Status Monitoring Sys2011-11-04
DELTEX MEDICAL LIMITED
DELTEX MEDICAL CARDIOQ EDM2011-10-20
Donna Connolly [DELTEX MEDICAL LIMITED]
I2S Doppler Probe (6 hour)2009-10-06
Donna Connolly [DELTEX MEDICAL LIMITED]
I2P Doppler Probe (24 hour)2009-10-06
Donna Connolly [DELTEX MEDICAL LIMITED]
I2C Doppler Probe (72 hour)2009-10-06
DELTEX MEDICAL LIMITED
I2S DOPPLER PROBE ( 6 HOUR), I2S DOPPLER PROBE (24 HOUR), I2C DOPPLER PROBE (72 HOUR), MODELS 9090-7015, 9090-70162009-01-29
Donna Connolly [DELTEX MEDICAL LIMITED]
DP240 (9070-7006)2007-12-07
Donna Connolly [DELTEX MEDICAL LIMITED]
CardioQ Cardiac Output and Fluid Status Monitoring System2007-12-07
Donna Connolly [DELTEX MEDICAL LIMITED]
CardioQ Cardiac Output and Fluid Status Monitoring System2007-12-07
Donna Connolly [DELTEX MEDICAL LIMITED]
CardioQ Cardiac Output and Fluid Status Monitoring System2007-12-07
Donna Connolly [DELTEX MEDICAL LIMITED]
CardioQ & CardioQ-EDM Roll Stand2005-04-04

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